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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01642927
Other study ID # FWA00000312-7
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date February 2012
Est. completion date December 2016

Study information

Verified date April 2023
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.


Description:

Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize: 1. That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring. 2. That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms. 3. That clinical events involving LVAD will have characteristic frequency spectra.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2016
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1)18 years of age or older 2)Advanced heart failure as defined by need for IABP or LVAD 3)One or more of the following: - Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group •= 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group •= 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group - Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group 4)Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care. Exclusion Criteria: 1. Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups) 2. Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)

Study Design


Locations

Country Name City State
United States Univeristy of Minnesota Lillehei Heart Institute Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Observation of pulse wave signatures in LVAD patients ongoing
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